BIRMINGHAM HIP RESURFACING (BHR) SYSTEM
FDA premarket approval P040033/S015 · decided 2010-03-09
Approval details
- PMA number
- P040033
- Supplement
- S015
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- BIRMINGHAM HIP RESURFACING (BHR) SYSTEM
- Generic name
- Prosthesis, hip, semi-constrained, metal/metal, resurfacing
- Applicant
- Smith & Nephew, Inc.
- Date received
- 2010-01-11
- Decision date
- 2010-03-09
- Days to decision
- 57 days
- Decision code
- APPR
- Product code
- NXT
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Memphis, TN
- Statement
- APPROVAL FOR THE ADDITION OF SURGICAL INSTRUMENTS FOR USE WITH THE BHR SYSTEM AND AN UPDATE TO THE SURGICAL TECHNIQUE TO REFLECT THE NEW SURGICAL INSTRUMENTS.
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